An interventional study of Zenith® Dissection Endovascular Graft in Aortic Dissection, sponsored by Cook Group Incorporated. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-06.
Sponsored by Cook Group Incorporated · Not applicable, Interventional, and Treatment
The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with aortic dissection.
386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's enrollment of 26 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Zenith® Dissection Endovascular Graft
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.
Also known as: Endovascular graft, Stent-graft
Number of Patients With Major Complications
Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.
Time frame: 30 days
| Milestone | Zenith® Dissection Endovascular Graft |
|---|---|
| Started | 26 |
| 30 days | 24 |
| Completed | 6 |
| Not completed | 20 |
| Withdrew: Death | 7 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Still be eligible for follow-up | 3 |
Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.
| participants | Zenith® Dissection Endovascular Graft |
|---|---|
| Paralysis or paraparesis unresolved after 30 days | 2 |
| Stroke | 4 |
| Retrograde Type A dissection | 2 |
| Renal failure requiring dialysis | 3 |
| Prolonged ventilation requiring tracheotomy | 3 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zenith® Dissection Endovascular Graft | — | 2/26 (7.7%) | 15/26 (57.7%) |
| Event | Zenith® Dissection Endovascular Graft |
|---|---|
| Rupture of the aorta at the original entry tearVascular disorders | 1/26 |
| Stroke, midbrain and cerebellarNervous system disorders | 1/26 |
| Event | Zenith® Dissection Endovascular Graft |
|---|---|
| Post-procedure transfusionVascular disorders | 7/26 |
| Pulmonary event requiring tracheostomy or chest tubeRespiratory, thoracic and mediastinal disorders | 5/26 |
| Ventilation > 24 hoursRespiratory, thoracic and mediastinal disorders | 5/26 |
| Arrhythmia requiring intervention or new treatmentCardiac disorders | 4/26 |
| StrokeNervous system disorders | 4/26 |
| Refractory hypertensionCardiac disorders | 3/26 |
| Renal failure requiring dialysisRenal and urinary disorders | 3/26 |
| Serum creatinine rise > 30% above baseline resulting in a persistent value > 2.0 mg/dlRenal and urinary disorders | 3/26 |
| Paralytic ileus > 4 daysGastrointestinal disorders | 2/26 |
| Pleural effusion requiring treatmentRespiratory, thoracic and mediastinal disorders | 2/26 |
| Age, Continuous(years) | Zenith® Dissection Endovascular Graft |
|---|---|
| Mean | 61.3 ± 15 |
| Gender(Participants) | Zenith® Dissection Endovascular Graft |
|---|---|
| Female | 7 |
| Male | 19 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Cook Group Incorporated